通用名称

ixekizumab

儿科标签批准日期

2020/3/26 0:00:00

特定指示/秒

Moderate-to-severe plaque psoriasis

标签更改摘要

- Safety and effectiveness have been established in pediatric patients 6 years to less than 18 years with moderate-to-severe plaque psoriasis. - Safety and effectiveness in other pediatric indications and for pediatric patients less than 6 years of age have not been established. - In the clinical trial, Crohn’s disease occurred at a greater frequency in the treatment group (0.9%) than the placebo group (0%) during the 12-week, placebo-controlled period. Crohn’s disease occurred in a total of 4 Talkz treated patients (2.0%) in the clinical trial. - Safety profile was similar to those observed in adults with plaque psoriasis with the exception of the frequencies of conjunctivitis (2.6%), influenza (1.7%), and urticaria (1.7%). - Information on dosing, adverse reactions, PK parameters and clinical trial. - Postmarketing study.

治疗类别

Dermatitis Agents

立法类型

PREA Only

产品说明书链接